New Data Illustrates Variances in the Use of Evidence-Based Heart Failure TreatmentsMINNEAPOLIS--(BUSINESS WIRE)--Nov 7, 2007 - New baseline data from the largest study of United States-based heart failure (HF) patients in the outpatient setting demonstrate significant underutilization of many guideline-indicated life-saving medical and device therapies. In fact, data from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) study show substantial variances in the use of all guideline-recommended treatments for HF patients. Findings from IMPROVE HF were presented today in a poster session at Scientific Sessions 2007, the annual congress of the American Heart Association. The study is sponsored by Medtronic, Inc., (NYSE:MDT).
According to the baseline results, the use of ACE inhibitors/ARBs (angiotensin II receptor blockers) and beta-blockers were relatively high in patients eligible for these therapies (80 percent and 86 percent of eligible patients, respectively). However, fewer patients received other life-saving treatments and devices for which they were eligible based on current medical guidelines. These included:
-- Aldosterone antagonists (36 percent of eligible patients)
-- Anticoagulation for atrial fibrillation (69 percent of eligible patients)
-- Cardiac resynchronization therapy (CRT), including both CRT-defibrillators (CRT-D) and CRT-pacemaker devices (39 percent of eligible patients)
-- Implantable cardioverter defibrillator (ICD) therapy, including both ICD-only and CRT-D devices (51 percent of eligible patients)
-- HF education (61 percent of eligible patients)
"More than five million Americans have heart failure, and while there are clear guidelines for how best to treat these patients, appropriate therapies are still underutilized," said Clyde Yancy, M.D., co-chair of the IMPROVE HF Scientific Steering Committee and medical director at the Baylor Heart and Vascular Institute, Baylor University Medical Center, in Dallas. "Based on the data from this study, the medical community is presented with an opportunity to improve the quality of care for heart failure patients."
"This is the first study of its kind to document the extent in which heart failure patients in the outpatient cardiology practice setting are receiving optimal treatment, as defined by the most recent treatment guidelines," said Gregg C. Fonarow, M.D., co-chair of the IMPROVE HF Scientific Steering Committee and professor of medicine at the University of California at Los Angeles. "The new data demonstrate that alarming treatment gaps exist in the use of evidence-based, guideline recommended therapies in eligible patients with heart failure."
Earlier IMPROVE HF analyses showed:
-- Less than 30 percent of patients assessed at baseline were being treated with all therapies for which they were eligible.
-- Women were less likely than men to receive an ICD when indicated, education about their condition, or anticoagulation treatment for atrial fibrillation.
-- Older patients were less likely than younger patients to receive certain types of guideline-indicated interventions - particularly ICD/CRT-D therapy.
The IMPROVE HF study (POSTER #3280/C81: Heart Failure Quality of Care in the Outpatient Cardiology Practice Setting: A Report from IMPROVE HF) will be available for viewing from 9 a.m. - 5 p.m. EDT, and will be presented from 9:30 - 11:30 a.m. EDT Wednesday, Nov. 7, in West Hall A1/A2.
About IMPROVE HF
IMPROVE HF is the first of its kind, large-scale, prospective study involving approximately 40,000 HF patients from approximately 150 cardiology practices in the United States.
The study is designed to:
-- Characterize the management of chronic systolic heart failure (EF less than or equal to 35 percent) in the outpatient care setting;
-- Assess the effects of practice-specific performance-improvement measures on patient care;
-- Provide insight into the issues that impede implementation of HF treatment guidelines, such as the documentation of NYHA (New York Heart Association) functional class; and
-- Identify methods and tools that will improve the quality of HF care in the outpatient setting, such as patient education.
The primary objective of the study is to determine if there is a relative 20 percent or greater improvement in the use of at least two of the following seven treatments/study performance measures: ACE inhibitors/ARBs; beta-blockers; aldosterone antagonists; anticoagulation for AF; ICD therapy (ICD-only and CRT-D devices); CRT therapy (CRT-D and CRT only devices); and HF patient education such as smoking cessation, exercising, diet, and restricting salt intake.
Chart reviews were conducted at baseline, and as part of the ongoing study and performance improvement initiative, will be conducted again at six, 12, 18, and 24 months. All study data are being collected and analyzed by an independent clinical research organization.
"Medtronic is firmly committed to advancing patient care through the support of clinical research such as the IMPROVE HF study," said Pat Mackin, senior vice president and president of the Cardiac Rhythm Disease Management business at Medtronic. "We're hopeful that deeper understanding and application of treatment guidelines will ultimately help improve and save more lives."
Additional information about the IMPROVE HF study is available at: www.IMPROVEHF.com.
About Heart Failure and Treatment Guidelines
Heart failure is typically a late manifestation of one or more other cardiovascular diseases, including coronary artery disease (CAD), hypertension, and valvular disease. Chronic heart failure occurs when the heart is unable to pump enough blood to sustain adequate circulation in the body's tissues. Approximately 5.2 million Americans suffer from HF and more than 550,000 new cases are estimated to develop each year. Heart failure is the most costly cardiovascular disease in the U.S., at an estimated $40 billion per year. Estimates for the global population (22 million) are near $80 billion.
In 2001, the American College of Cardiology and American Heart Association (ACC/AHA) published the first guidelines for the evaluation and management of chronic heart failure in adults. The ACC/AHA published updated HF treatment guidelines in 2005. In 2006, the Heart Failure Society of America (HFSA) released guidelines for living with and treating HF, which complement the ACC/AHA guidelines that recommend device therapy as standard of care for HF patients already on optimal medical therapy who meet CRT and/or ICD indications. The use of published HF treatment guidelines has been shown to reduce the risk of death by up to 77 percent.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.
Any statements made about anticipated regulatory review or approval are forward-looking statements subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
Kyra Schmittm, 763-514-4477
Onsite at AHA: 612-670-9011
Jeff Warren, 763-505-2696
Onsite at AHA: 612-819-7360
Posted: November 2007